{"id":1813,"date":"2016-02-06T17:12:00","date_gmt":"2016-02-06T22:12:00","guid":{"rendered":"https:\/\/nanobiotix.com\/resource\/phase-i-data-nbtxr3-soft-tissue-sarcoma-bonvalot-et-al\/"},"modified":"2024-10-29T08:50:29","modified_gmt":"2024-10-29T12:50:29","slug":"phase-i-data-nbtxr3-soft-tissue-sarcoma-bonvalot-et-al","status":"publish","type":"resource","link":"https:\/\/nanobiotix.com\/fr\/resource\/phase-i-data-nbtxr3-soft-tissue-sarcoma-bonvalot-et-al\/","title":{"rendered":"Phase I data NBTXR3 Soft Tissue Sarcoma – Bonvalot et al."},"content":{"rendered":"

[vc_row padding_top=”0″ padding_bottom=”0″ section_container_layout=”full-width” remove_horizontal_padding=”yes” module_type=”bg-color” gutter_size=”yes” equal_height=”yes” bg_color=”#28282e”][vc_column][vc_row_inner padding_top=”0″ padding_bottom=”0″ gutter_size=”yes” equal_height=”yes”][vc_column_inner column_paddings=”105″ column_position_vertical=”middle” column_min_height=”700″ column_min_height_sm=”400″ column_min_height_xs=”350″ module_type=”bg-image” bg_image=”99″ mask_fx=”yes-mask” mask_color_mode=”palette” mask_bg_color_palette=”main-mask” animation_fx=”yes-animation” animation_delay=”200″ animation_offset_scroll_down=”90″ width=”1\/2″ animation_in=”fadeInUp”][vc_empty_space height=”60px” responsive_lg=”hidden” responsive_md=”hidden”][az_box_icons box_icon_title=”Authors” box_icon_color_mode=”on-the-fly” icon_visibility=”yes-icon” icon_type=”font” icon=”fa fa-edit” icon_color_mode=”on-the-fly” icon_size=”50″ box_icon_color=”#ffffff” icon_color=”#ffffff”]Sylvie Bonvalot1<\/span>, C ecile Le Pechoux2<\/span>, Thierry De Baere2<\/span>, Guy Kantor3<\/span>, Xavier Buy3<\/span>, Eberhard Stoeckle3<\/span>, Philippe Terrier2<\/span>, Paul Sargos3<\/span>, Jean Michel Coindre3<\/span>, Nathalie Lassau2<\/span>, Rafik Ait Sarkouh4<\/span>, Mikaela Dimitriu4<\/span>, Elsa Borghi4<\/span>, Laurent Levy4<\/span>, Eric Deutsch2<\/span>, and Jean-Charles Soria2<\/span>
\nNanobiotix, 60 rue de wattignies, 75012 Paris, France<\/span>[\/az_box_icons][vc_empty_space height=”60px” responsive_lg=”hidden” responsive_md=”hidden”][\/vc_column_inner][vc_column_inner column_paddings=”105″ column_position_vertical=”middle” module_type=”bg-color” animation_fx=”yes-animation” animation_delay=”300″ animation_offset_scroll_down=”90″ width=”1\/2″ bg_color=”#ffffff” animation_in=”fadeInUp”][vc_empty_space height=”60px” responsive_lg=”hidden” responsive_md=”hidden”][az_box_icons box_icon_title=”Summary” icon_visibility=”yes-icon” icon_type=”font” icon=”az-icon az-icon-layers2″ icon_color_mode=”on-the-fly” icon_color=”#28282e” icon_size=”50″]Purpose:<\/strong> This phase I study aimed to determine the recommended dose (RD), safety profile, and feasibility of a procedure combining intratumoral injection of hafnium oxide nanoparticles (NBTXR3; a radioenhancer) and external beam radiotherapy (EBRT) for preoperative treatment of adults with locally advanced soft tissue sarcoma (STS).<\/p>\n

Experimental Design:<\/strong> Patients had a preoperative indication of EBRT for STS of the extremity or trunk. Baseline tumor volume (TV) was calculated by MRI. NBTXR3 was injected percutaneously into tumors at 53.3 g\/L. Dose escalation was based on four levels equivalent to 2.5%, 5%, 10%, and 20% of baseline TV. NBTXR3 was visualized in the tumor 24 hours postinjection, and EBRT was initiated (50 Gy over 5 weeks). Surgery was performed 6 to 8 weeks after EBRT completion.<\/p>\n

Results:<\/strong> Twenty-two patients completed NBTXR3 injection, EBRT, and surgery and were followed for a median 22 months (range, 6-40). At NBTXR3 20% of TV, two dose-limiting toxicities occurred: injection-site pain and postoperative scar necrosis. The RD was defined as 10%. No leakage of NBTXR3 into surrounding tissues occurred; intratumor NBTXR3 levels were maintained during radiotherapy. At the RD, median tumor shrinkage was 40% (range 71% shrinkage, 22%increase);median percentage of residual viable tumor cells was 26% (range, 10%-90%). Patients receiving 20% of TV demonstrated pathologic complete responses. Seven grade 3 adverse events occurred, which were reversible.<\/p>\n

Conclusion:<\/strong> A single intratumoral injection of NBTXR3 at 10% of TV with preoperative EBRT was technically feasible with manageable toxicity; clinical activity was observed. Clin Cancer Res; 1-10. 2016 AACR.[\/az_box_icons][vc_empty_space height=”60px” responsive_lg=”hidden” responsive_md=”hidden”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"wds_primary_resource_type":0,"wds_primary_data_type":0,"wds_primary_indication":0,"wds_primary_platform_type":0,"footnotes":""},"resource_type":[23,24],"data_type":[25],"indication":[27],"platform_type":[36],"class_list":["post-1813","resource","type-resource","status-publish","hentry","resource_type-no-rights","resource_type-publications","data_type-clinical","indication-sts","platform_type-nbtxr3"],"acf":[],"_links":{"self":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource\/1813","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource"}],"about":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/types\/resource"}],"version-history":[{"count":0,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource\/1813\/revisions"}],"wp:attachment":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=1813"}],"wp:term":[{"taxonomy":"resource_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource_type?post=1813"},{"taxonomy":"data_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/data_type?post=1813"},{"taxonomy":"indication","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/indication?post=1813"},{"taxonomy":"platform_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/platform_type?post=1813"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}